Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

March 18, 2015 updated by: Hoya Surgical Optics, Inc.

Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • E. Shea Blvd, Suite C101, Arizona, United States, 85260
        • Schwartz Laser Eye Center
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Katzen Eye Care and Laser Center
      • Miami, Florida, United States, 33176
        • Center for Excellence in Eye Care
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Eye Surgeons of Indiana
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Eye Health Vision Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
  • Have clear intraocular media
  • Have potential Best Corrected Visual Acuity of 20/40 or better
  • Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse

Exclusion Criteria:

  • Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
  • Are monocular
  • Have current ocular infection
  • Are taking systemic steroids or other anti-metabolites
  • Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational intraocular lens
iSert 251 intraocular lens
Device: iSert 251 intraocular lens
aphakic intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 4 to 6 months
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
4 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications and Adverse Events
Time Frame: 4 to 6 months
Number of Participants with Complications or Adverse Events
4 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoya Surgical Optics, Inc.

Investigators

  • Study Director: Kees den Besten, Hoya Surgical Optics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-N251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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